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|Product name||Catalog no.||Technology||Packaging|
|GeneProof Hepatitis C Virus (HCV) PCR Kit||HCV/PLUS/025||real-time PCR||25 reactions|
|GeneProof Hepatitis C Virus (HCV) PCR Kit||HCV/PLUS/100||real-time PCR||100 reactions|
|Indication||in vitro diagnostic medical device|
|Intended User||For professional use in laboratories with trained staff|
|Target Analysis||qualitative and quantitative|
|Target Sequence||conservative region of 5' UTR sequence|
|Analytical Specificity||HCV genotype 1–8, 100 %|
|Analytical Sensitivity (LoD)||
Reaches up to 7.87 IU/ml with the probability of 95% (on AcroMetrix
|Linear Range||1010 - 25 IU/ml with precision of ± 0.5 log|
|Dynamic Range||1010 - 7.87 IU/ml|
|Validated Specimen||Plasma, serum|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||
croBEE NA16 Nucleic Acid Extraction System
croBEE Real-Time PCR System*
|Required Detection Channels||FAM, HEX|
|External Quality Assessment||Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results available at www.geneproof.com|
|Regulatory Status||CE1023 IVD for in vitro Diagnostic Use|